RegulatoryOfficial

CHMP backs Kuraci's Donrafylix, a biosimilar of NovoRapid insulin aspart

🇪🇺 EMA · Fri 13 Nov 2026

The EMA committee adopted a positive opinion on 12 November 2026 for a biosimilar fast-acting insulin to treat diabetes mellitus in patients aged one year and above.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Donrafylix (insulin aspart). The positive opinion was adopted on 12 November 2026, and EMA published it on 13 November.

Donrafylix is a biosimilar of NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999. EMA states that data show comparable quality, safety and efficacy to the reference product. The applicant is Kuraci BV, and the product will be available as a 100 units/ml solution for injection.

The indication is the treatment of diabetes mellitus in adults, adolescents and children aged one year and above. Insulin aspart (ATC code A10AB05) is a fast-acting insulin with a more rapid onset of action than human soluble insulin. It lowers blood glucose by promoting glucose uptake into muscle and fat cells and by inhibiting glucose output from the liver.

The opinion is not yet an authorisation. As is standard in the centralised procedure, the European Commission takes the final decision. EMA says the full summary of product characteristics (SmPC) will be published in all official EU languages once the Commission has granted the authorisation. The EMA product number is EMEA/H/C/006864.

What it means for your team

  • Market access: a further insulin aspart biosimilar is heading for EU authorisation. The source gives no launch timing or pricing, so competitive impact on NovoRapid cannot yet be assessed.
  • Regulatory: watch for the European Commission decision, after which the SmPC will be published in all EU languages.
  • Pharmacovigilance: detailed prescribing information and any product-specific safety provisions will become available only with the SmPC and the final EPAR documents.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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